# Aksys, Ltd.

- Location (FDA's records): Lincolnshire, IL
- FDA decisions: 1 (2002–2002): 1 510(k) clearance
- Product codes: KDI (1)
- Predicates its devices cite: 11 (0 its own); citations of its devices by later devices: 5 (0 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Gambro, Inc.: 3 (https://510kreport.com/company/gambro)
- Fresenius USA, Inc.: 2 (https://510kreport.com/company/fresenius-usa)
- Colorado Medical, Inc.: 1 (https://510kreport.com/company/colorado-medical)
- Minntech Corp.: 1 (https://510kreport.com/company/minntech)
- Zyzatech Water Systems, Inc.: 1 (https://510kreport.com/company/zyzatech-water-systems)
- National Medical Care, Medical Products Div., Inc.: 1 (https://510kreport.com/company/national-medical-care-medical-products-div)
- Dial Medical of Florida, Inc.: 1 (https://510kreport.com/company/dial-medical-of-florida)
- Millipore Corp.: 1 (https://510kreport.com/company/millipore)

## Firms that cite its devices most
- Nxstage Medical, Inc.: 2 (https://510kreport.com/company/nxstage-medical)
- Fresenius Medical Care: 1 (https://510kreport.com/company/fresenius-medical-care)
- Nephros, Inc.: 1 (https://510kreport.com/company/nephros)
- Deka Research and Development: 1 (https://510kreport.com/company/deka-research-and-development)

## Its most-cited devices
- K010131: PHD Personal Hemodialysis Instrument-1M101, PHD Water Pre-Treatment Kit-1W605,PHD Hard Plumbing Kit-1W604, PHD Blood Tub (2002), cited by 5

## Recent decisions
- K010131: PHD Personal Hemodialysis Instrument-1M101, PHD Water Pre-Treatment Kit-1W605,PHD Hard Plumbing Kit-1W604, PHD Blood Tub (Mar 26, 2002)

Source page: https://510kreport.com/company/aksys